Bioequivalence Impact Factor
Bioequivalence is the similarity of two
drugs which share patients with the same desired outcome.
Pharmacokinetic tests will be carried out to assess whether the core characteristics of a marketable brand and a possible generic version share. There must be bioequivalence or pharmaceutical equivalence demonstrating that the two
drugs release the active ingredient into the bloodstream at the same amount, at the same rate and have the same consistency. Bioequivalence does not require the full process of clinical trials the name-brand version had to go through. Instead, generic
drugs must only be bioequivalent, meaning that the company applying for approval must take the following steps: testing the generic drug against the brand name drug on two small groups of test subjects. Draw timed samples of each patient's blood. Demonstrate through statistical analysis that any difference in the bioavailability of the drug in participants taking the version of the brand name versus those taking the generic version is not clinically significant. Although bioequivalent
drugs offer many benefits for patients, there are still some concerns. Problems with bioequivalence have been identified by doctors and patients that many licensed generic
drugs don't have the same desired effect as their branded counterparts. Certain classes of specific chemical reactions are more prone to these discrepancies. All of this involves poorly absorbed drugs, chiral
drugs and other complex pathways for delivery. When prescribing ant-epileptic
drugs and blood thinners, physicians are vigilant in moving patients from branded to generic products, or between various generic manufacturers.
High Impact List of Articles
Relevant Topics in General Science